A Dhaussy


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A Dhaussy

  1. 1. Applications for registration of plant protection products - The applicant’s view Aurélie DHAUSSY, ECPA Monsanto Symposium 23 March 2009
  2. 2. Current legislative situation Legislative framework for plant protection products in the European Union Directive 91/414/EEC currently in place To be replaced by new Regulation 1107/2009 Published 24 November 2009 Entered into force on 14 December 2009 Provisions will apply from 14 June 2011, to allow adoption of implementing measures
  3. 3. Basics of Directive 91/414/EEC Active substance approved at EU level Plant protection product Authorised at Member State level Authorisation includes details of each authorised use
  4. 4. PPP dossiers are substantial The legislation detailing the data requirements and evaluation principles are substantial (150+ pages) The evaluation work covers 200+ studies per active substance with additional studies for each product and use
  5. 5. PPP dossiers are substantial
  6. 6. Basics of Directive 91/414/EEC Data requirements and evaluation: Annex II – Requirements for the dossier to be submitted for the inclusion of an active substance in Annex I (approval) Annex III - Requirements for the dossier to be submitted for the authorization of a plant protection product Annex VI – Uniform principles for evaluation and authorisation of chemical plant protection products
  7. 7. Directive 91/414: Ensuring safe PPP use “one of the most important ways of protecting plants and plant products ... is to use plant protection products” (3rd recital) recognises that pest control must have an environmental impact that needs to be managed: Article 4.1(b)(v) “it has no unacceptable influences on the environment, having proper regard to … its impact on non-target species” Annex III, 6.2 “… assess whether the dose is the minimum necessary to achieve the desired effect” development of resistance: Annex III, 6.3 “…. management strategy designed to minimise the likelihood of resistance …”
  8. 8. New Regulation 1107/2009: PPP authorisation A plant protection product…shall meet the following requirements: (a) be sufficiently effective; (b) have no… harmful effect on human health… (c) not have any unacceptable effects on plants or plant products; (d) not cause unnecessary suffering and pain to vertebrates to be controlled; (e) have no unacceptable effects on the environment, having particular regard to…: (i) its fate and distribution in the environment…; (ii) its impact on non-target species…; (iii) its impact on biodiversity and the ecosystem. Article 4.3
  9. 9. New Regulation 1107/2009: PPP authorisation 1. The authorisation shall define plants or plant products…on which and the purposes for which the plant protection product may be used. 2. The authorisation shall set out the requirements relating to the… use of the plant protection product… 3. The requirements… shall… include where applicable: (a) the maximum dose per hectare in each application; (b) the period between the last application and harvest; (c) the maximum number of applications per year. Article 31
  10. 10. New Regulation 1107/2009: Efficacy and resistance reporting The holder of an authorisation for a plant protection product shall report annually to the competent authorities of the Member States which authorised his plant protection product if he has any information available relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment Article 56.4
  11. 11. Conclusion Directive 91/414/EEC (and the new Regulation) requires a detailed evaluation (and monitoring) of: The active substance The plant protection product, and Each authorised use of the product Data on PPP uses on GM crops have been submitted and evaluated in a number of Member States Authorities responsible for 91/414 and successor legislation will continue to have jurisdiction in PPP approval and monitoring matters - for all uses!